Generic drugs and branded
drugsby Dr. Carlo FonsekaMA, MBBS, PhD
Fellow of the Ceylon College of Physicians (h.c.)
Fellow of the Sri Lanka College of General Practitioners (h.c.)
Emeritus Professor of Physiology, Universities of Colombo &
Kelaniya
Former Chairman of the Board of Management of the Postgraduate
Institute of Medicine

Continued from Yesterday

ii. Dr. DPA’s sweeping statement that "the
anti-epileptic drugs (generic) imported on Prof. Senake Bibile’s
recommendation never controlled fits and the entire stock had to
be destroyed" is totally false. He has not cited a shred of
supporting evidence. It is possible that he knew of a patient
whose fits during a particular phase of the illness continued
unabated despite taking a specific anti-epileptic drug supplied
by the SPC. Given his notorious tendency to confuse
chronological succession with causal link, he may well have
jumped to the conclusion that anti-epileptic drugs (generic)
imported on Prof. SB’s recommendation never controlled fits. If
Dr. DPA bothers to read any good modern textbook of Clinical
Pharmacology he will learn that when a patient is given a drug,
the response is the resultant of at least ten different factors.
The quality of the drug is only one among them. (But I will not
elaborate on that matter here. I participate in this debate not
to contribute to the Continued Medical Education (CME) which Dr.
DPA seems to require so badly, but to clarify things for people
like my friend EJdeS.) I challenge him once again to furnish the
evidence for his statement that large stocks of anti-epileptic
drugs had to be destroyed during Prof. SB’s time as Chairman of
the SPC. The question of bioequivalence of some generic
anti-epileptic drugs may have arisen. But there is no evidence
that large stocks had to be destroyed. I am given to understand
that under the terms of the relevant contracts, the suppliers
are obliged to replace any defective stocks free of charge.

iii. What Dr. DPA says about a batch of
amoxycillin capsules is perfectly true. A fraudulent local
manufacture had delivered to the SPC dud capsules without
antibiotic which, of course, did not work. Dr DPA says that he
believes that a large number of patients who received those dud
capsules would have died. If he truly believes that all patients
who don’t swallow all the antibiotics that doctors prescribe for
them necessarily die, he has still to learn about the phenomenon
called patient "non-compliance". My friend EJdeS is one who by
his own admission (innocently) believes that his body and soul
are kept together by the drugs he religiously swallows. For the
benefit of his health and peace of mind let me quote from
Clinical Pharmacology by Bennett & Brown: "Having obtained the
medicine, some 25-50% (sometimes even more) of patients either
fail to follow the instruction to a significant extent (taking
50-90% of the prescribed dose) or they do not take it at all."
(p. 19) The good news is that the vast majority of them live to
tell the tale. It is mainly their physiology that keeps them
going and not the poisons they swallow in small doses in the
form of drugs. But that is another story. To return now to the
story of the dud amoxycillin capsules: this act of outright
fraud does not prove that generic drugs do not work. What it
demonstrates is the greed and fraud of people in the drug
industry and the importance of unfailing vigilance in preventing
corrupt practices by undertaking rigorous quality assurance of
drugs.

iv. What Dr. DPA says about Prof. CC de Silva
and Vitamin A is again anecdotal and I for one will not accept
on Dr. DPA’s authority that children went blind as a result of
this alleged lapse. I knew Prof. CC de Silva very well, first as
his student and then as a colleague in the UCFM. If as Dr. DPA
alleges children went blind as the result of taking dud capsules
of Vitamin-A supplied by the SPC, Prof. CCdeS would surely have
gone public about it and made one almighty fuss. To my knowledge
he didn’t. Let Dr. DPA furnish the evidence required to prove
that children went blind as a result of taking dud capsules of
Vitamin-A supplied by the SPC or be damned as a retailer of
imaginary horror stories for the benefit of the drug industry.

In this context it is relevant to remember that
the SPC happens to be the only drug importing institution in Sri
Lanka which has a well equipped Drug Quality Assurance
Laboratory. Most varieties of drugs that the SPC imports are
scheduled to be tested for quality on at least three occasions,
namely, when they are submitted for registration; on arrival of
their first stocks in the country; and at some point during
their circulation to patients. About 5-10% of drugs so tested
fail the test and are promptly eliminated. In Sri Lanka
proportionately more generics fail the tests than do proprietary
drugs, although in developed countries the failure rates of the
generic and branded categories are not significantly different.
That is why standard text-books unhesitatingly recommend
prescription of drugs by generic names. In Sri Lanka although
drugs imported by the SPC are subjected to quality assurance
tests, proprietary drugs imported by the private sector are not
tested for quality at all. Importers of proprietary drugs and
doctors who habitually prescribe them seem to believe without a
whisper of doubt that drug companies with famous names are
models of scientific integrity and ethical propriety. The stark
truth about these drug companies has been laid bare recently by
Dr. Marcia Angell, MD. Currently she is a professor of Social
Medicine in the Harvard Medical School. Before that she was
Editor in Chief of the prestigious New England Journal of
Medicine. TIME magazine has named her one of the 25 most
influential people in America. In her book titled ‘THE TRUTH
ABOUT THE DRUG COMPANIES. HOW THEY DECEIVE US AND WHAT TO DO
ABOUT IT’ published in 2004 she says; " … defrauding the
government by rigging prices and offering kickbacks is not the
only charge that drug companies are facing…other charges include
marketing drugs for unapproved uses and misleading advertising.
Still others allege substandard manufacturing practices… four of
those companies… pleaded guilty to criminal charges."
(Chapter12) It is the exorbitant profits that such companies
make which some doctors like Dr. DPA implicitly promote by
touting brand names. Dr. DPA’s stated reason for doing so is to
save "dying heart patients" (Don’t make me laugh!). If patients
who receive branded (proprietary) drugs imported by the private
sector die, most doctors do not even consider the possibility
that the drugs may have been substandard. All concerned
implicitly attribute the deaths to the bad karma of the patients
on the ground that they died even after receiving the most
expensive drugs on earth!

3. "All the essential life saving drugs used
today have been discovered by famous brand drug companies"

Perhaps the most authoritative comment on this
matter would be to quote from Dr. Marcia Angell’s book cited
above: "As hard as it is to believe, only a handful of truly
important drugs have been brought to market in recent years and
they were mostly based on taxpayer-funded research at academic
institutions, small biotechnology companies or the National
Institutes of Health (NIH). The great majority of "new" drugs
are not new at all but merely variations of older drugs already
on the market. These are called "me-too" drugs. The idea is to
grab a share of an established lucrative market by producing
something very similar to a "top-selling" drug. For instance, we
now have six statins …on the market to lower cholesterol… all
variants of the first." (p. xv - xvi) Dr. Angell has marshalled
evidence that in recent times a large proportion of the
expenditure of the big drug companies has been on "Marketing
Masquerading as Education" and "Marketing Masquerading as
Research". (These phrases are the headings of chapter 8 and 9
respectively of Dr. Angell’s "tell it like it is" book on the
drug industry.)

4. "Less than 0.5% of all drugs available in SL
pharmacies are pure generic drugs and the remaining 99.5%
consist of both cheap and expensive brands"

In The Island of 9 January 2008 Dr. Mahinda de
Silva, a physician who has worked for 23 years in New York City
and knows a thing or two about the gigantic racket called the
drug industry, has rightly dismissed the above assertion of Dr.
DPA as "gibberish".

The matter is indeed a bit confusing. Let me
state my understanding of it as simply as I can.

i. Every drug has three names, namely, a
chemical name, a generic name and a trade name. The chemical
name is not relevant to practical medicine.

ii. The generic name of a drug is officially
given by globally accepted international agencies. It is also
known as the official or approved name. It is not the commercial
property of any drug company. So it is also called the
non-proprietary name. Thus generic name, official name, approved
name and non-proprietary name are synonyms. When there are four
terms to describe one and the same thing some confusion is
inevitable.

iii. When a drug company markets a drug it has
developed it almost always gives it a name which is easier to
remember than its generic name. This is the trade name or brand
name or proprietary name of the drug. For example, one brand
name for Paracetamol is Panadol; for Aspirin one brand name is
Disprin; for Diazepam one brand name is Valium.

iv. A company which develops a drug and markets
it under a trade name or brand name patents the product and the
trade name. During the period the patent operates the drug
becomes known to the public only by the trade name or brand name
given to it by the innovator company.

During this period no other company can lawfully
manufacture and market it.

v. When the patent period of a drug expires,
companies other than the innovator company can lawfully
manufacture it and market it. But they have to do so under the
generic name of the drug or under new brand names which are
different from the brand name which had been given to it by the
innovator company. So it comes about that a generic drug maybe
known to the public either by its generic name or by several
trade names or brand names. For example, the drug whose generic
name is Salbutamol is marketed under its generic name Salbutamol
itself and under trade names such as Ventolin, Volmax and Salmol.

vi. A generic drug is simply a copy of an
original brand name drug whose patent period has expired.
Therefore chemically, a generic drug is the same as its branded
counterpart. This point must be clearly remembered during this
debate. So let me repeat that a generic drug is nothing but a
branded drug whose patent period has expired. Theoretically,
therefore, other things being equal, how on earth could a
generic drug be worse than the branded product?

vii. It goes without saying that all proprietary
drugs have brand names. In addition, as indicated above, generic
drugs can also have brand names. Thus both proprietary drugs and
non-proprietary or generic can have brand or trade names. If
this sounds a bit confusing EJdeS should recall the silly joke
used by our political enemies to taunt us in our undergraduate
days: "All commies are jokers; but all jokers are not commies;
because some are Trots". By the same logic, all proprietary
drugs are branded; but all branded drugs are not proprietary;
because some are generics.

viii. If a country does not recognise drug
patent rights, companies other than the one which originally
developed and marketed a given drug would be free to manufacture
and market it. In this business, patents are of two kinds,
namely product patents and process patents. A process patent
covers the specific chemical process by which a drug is
manufactured. India recognises process patents but not product
patents. Just as there’s more ways than one to skin a cat, there
can be several chemical ways of manufacturing a given drug.
Because India recognises only process patents and not product
patents, once a drug appears in the market, various companies
may manufacture it using processes different from the process
used and patented by the innovator company. This generates
commercial competition between drug companies. Such competition
is one reason why drugs manufactured in India can be very cheap.

ix. The great thing about generic drugs is that
they are almost always cheaper, often unbelievably cheaper, than
the branded drugs of which they are true copies. Being the same
chemically they have to be equally effective.

x. That is why in the interest of patients, the
case for prescribing by generic names becomes unanswerable and
compelling. This must be why our academic clinicians who are
also world class clinical researchers like Prof Janaka De Silva
and Prof Nimal Senanayake are not known to oppose prescription
by generic names. In fact, Prof Janaka De Silva is the editor of
an Online Appendix to Clinical Medicine by Kumar&Clark which
forthrightly and unequivocally recommends that "all drugs should
be prescribed by their generic (approved) names rather than
their brand ones" as I quoted in the opening paragraph of this
article. Only hack clinicians are dogmatic about the superiority
of branded drugs.

5. "When doctors prescribe drugs using generic
names it is the pharmacist who decides which cheap brand should
be issued to the patients"

EJdeS may be amused to hear that one of the
three main reasons given in Clinical Pharmacology by Bennett &
Brown for advocating the habitual prescription of drugs by
generic names is "convenience". How come "convenience" you may
wonder. It is like this. When a drug is prescribed by a
particular brand name the pharmacist is obliged to supply that
brand and none other. If that brand is out of stock the patient
does not get the drug at all. To remedy this, the patient may
have to meet by appointment the extremely busy doctor who
prescribed the branded drug and perhaps pay him another fee. On
the other hand, when a drug is prescribed by generic name the
pharmacist is free to supply whatever version of it is in stock.
Unfortunately, in Sri Lanka we still don’t have enough qualified
pharmacists. Therefore in the interests of patients, the
practical course for doctors to adopt at present would be to
prescribe by generic names and specify the brands they recommend
to patients.

To resolve this matter in a rational way the
fundamental question to which an answer must be found is the
following: Which category of medical professional is best
equipped scientifically and academically to determine which drug
is the best treatment for a given disease? The answer, as
already indicated, is Clinical Pharmacologists. It is certainly
not hack clinicians like Dr. DPA who on the basis of their
un-audited, unmonitored, uncritical, anecdotal clinical
experience passionately believe that they know best what is good
for their patients. For such doctors forty-three years of
experience may mean nothing more than one year’s mistakes
multiplied by 43!

Having dealt with the five matters raised by my
friend EJdeS I will conclude this contribution to the debate by
remarking that when the history of newspapers in this country
comes to be written, The Island will surely merit a high place
of honour for devoting so much space for promoting open debates
like this in the public interest.